Division of General Internal Medicine, Montefiore Health System, Bronx, New York, USA
Division of General Internal Medicine, Montefiore Health System, Bronx, New York, USA.
BMJ Open. 2020 Dec 29;10(12):e043400. doi: 10.1136/bmjopen-2020-043400.
In the USA, opioid analgesic use and overdoses have increased dramatically. One rapidly expanding strategy to manage chronic pain in the context of this epidemic is medical cannabis. Cannabis has analgesic effects, but it also has potential adverse effects. Further, its impact on opioid analgesic use is not well studied. Managing pain in people living with HIV is particularly challenging, given the high prevalence of opioid analgesic and cannabis use. This study's overarching goal is to understand how medical cannabis use affects opioid analgesic use, with attention to Δ9-tetrahydrocannabinol and cannabidiol content, HIV outcomes and adverse events.
We are conducting a cohort study of 250 adults with and without HIV infection with (a) severe or chronic pain, (b) current opioid use and (c) who are newly certified for medical cannabis in New York. Over 18 months, we collect data via in-person visits every 3 months and web-based questionnaires every 2 weeks. Data sources include: questionnaires; medical, pharmacy and Prescription Monitoring Program records; urine and blood samples; and physical function tests. Using marginal structural models and comparisons within participants' 2-week time periods (unit of analysis), we will examine how medical cannabis use (primary exposure) affects (1) opioid analgesic use (primary outcome), (2) HIV outcomes (HIV viral load, CD4 count, antiretroviral adherence, HIV risk behaviours) and (3) adverse events (cannabis use disorder, illicit drug use, diversion, overdose/deaths, accidents/injuries, acute care utilisation).
This study is approved by the Montefiore Medical Center/Albert Einstein College of Medicine institutional review board. Findings will be disseminated through conferences, peer-reviewed publications and meetings with medical cannabis stakeholders.
ClinicalTrials.gov Registry (NCT03268551); Pre-results.
在美国，阿片类镇痛药的使用和过量使用急剧增加。在这种流行的情况下，管理慢性疼痛的一种迅速扩大的策略是医用大麻。大麻具有镇痛作用，但也有潜在的不良影响。此外，它对阿片类镇痛药使用的影响尚未得到很好的研究。鉴于阿片类镇痛药和大麻使用的高流行率，管理艾滋病毒感染者的疼痛尤其具有挑战性。本研究的总体目标是了解医用大麻的使用如何影响阿片类镇痛药的使用，同时注意到Δ9-四氢大麻酚和大麻二酚的含量、艾滋病毒的结果和不良事件。
我们正在对 250 名患有和不患有艾滋病毒感染的成年人进行一项队列研究，这些成年人患有(a)严重或慢性疼痛，(b)目前正在使用阿片类药物，(c)新获得纽约医用大麻认证。在 18 个月的时间里，我们通过每 3 个月的面对面访问和每 2 周的在线问卷收集数据。数据来源包括：问卷；医疗、药房和处方监测计划记录；尿液和血液样本；以及身体功能测试。使用边缘结构模型和参与者的 2 周时间内的比较（分析单位），我们将研究医用大麻的使用（主要暴露）如何影响（1）阿片类镇痛药的使用（主要结果），（2）艾滋病毒的结果（艾滋病毒病毒载量、CD4 计数、抗逆转录病毒药物依从性、艾滋病毒风险行为）和（3）不良事件（大麻使用障碍、非法药物使用、转移、过量/死亡、事故/伤害、急性护理利用）。
这项研究得到了蒙蒂菲奥里医疗中心/艾伯特·爱因斯坦医学院机构审查委员会的批准。研究结果将通过会议、同行评议的出版物以及与医用大麻利益相关者的会议进行传播。
ClinicalTrials.gov 注册表（NCT03268551）；预结果。
